Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

syngo.CT Extended Functionality

K-Number: K192402 · 2019-09-20

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2019-09-20
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo.CT Extended Functionality is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2019-09-20 under approval number K192402. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the syngo.CT Extended Functionality?

syngo.CT Extended Functionality is a medical device that received FDA 510(k) clearance on 2019-09-20. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K192402.

When was syngo.CT Extended Functionality approved by the FDA?

syngo.CT Extended Functionality received FDA 510(k) clearance on 2019-09-20, under approval number K192402.

What company makes syngo.CT Extended Functionality?

syngo.CT Extended Functionality is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for syngo.CT Extended Functionality?

The FDA product code for syngo.CT Extended Functionality is JAK.

Related Clinical Trials

NCT07263815 EQUIP - Evaluation of Quality of Imaging on a Next-generation Total Body Pet Scan in Comparison to Conventional PET ACTIVE_NOT_RECRUITING

Other Devices by Siemens Medical Solutions USA, Inc.

K162302Somatom Confidence ® RT Pro K162971Multix Fusion Max K161795MAGNETOM ESSENZA K162541syngo Application Software K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT K162370syngo.via RT Image Suite

View all 248 devices →

Related Devices (Code: JAK)

K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. K163213Revolution CTGe Medical Systems, LLC K161157Vitrea CT Dual Energy Image ViewVital Images, Inc. K160723OnSight 3D Extremity SystemCarestream Health, Inc. K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑